Fresenius Kabi USA Recalls Batch 6402413 of 0.45% Sodium Chloride Injection Due to Lack of Sterility Assurance
Summary
Fresenius Kabi USA initiated a Class II drug recall for one batch (6402413) of 0.45% Sodium Chloride Injection, USP (250 mL freeflex bags) distributed nationwide, to Alaska, and to Puerto Rico. The recall was triggered by lack of assurance of sterility. FDA classified the recall on April 3, 2026. The affected batch expires February 29, 2028.
What changed
Fresenius Kabi USA initiated a voluntary Class II recall for one batch of 0.45% Sodium Chloride Injection, USP (Batch #6402413) due to lack of assurance of sterility. The recall affects product distributed throughout the United States, including Alaska and Puerto Rico.
Healthcare providers and facilities that have received or dispensed this specific batch should verify their inventory, quarantine any remaining units, and follow the firm's notification procedures. As a Class II recall, this indicates use of the product may cause temporary or reversible adverse health consequences.
Archived snapshot
Apr 20, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Fresenius Kabi USA, LLC
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0424-2026 · 20260415 · Ongoing · Voluntary: Firm initiated
Product
0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Us...
Reason for Recall
Lack of Assurance of Sterility
Affected Lot Numbers / Codes
Batch # 6402413, Exp Date: 02/29/2028
Firm Notification Method
Letter
Distribution
US Nationwide , Alaska, and Puerto Rico.
Initiated
20260311
FDA Classified
20260403
Product Registration
Brand: SODIUM CHLORIDE
Manufacturer: Fresenius Kabi USA, LLC
Application: ANDA208122
NDC: 63323-626
Drug Label Context (from openFDA)
The following is from the manufacturer's FDA-approved drug label, not recall-specific. Provided for context.
Indications & Usage
INDICATIONS AND USAGE: Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.
Dosage & Administration
DOSAGE AND ADMINISTRATION: The dose is dependent upon the age, weight and clinical condition of the patient. Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (see PRECAUTIONS ).
Contraindications
CONTRAINDICATIONS: None known.
Warnings
WARNINGS: 0.45% Sodium chloride injection should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. The intravenous administration of 0.45% Sodium chloride injection can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutive states is inversely proporti...
Adverse Reactions
ADVERSE REACTIONS: Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary. In addition to the above...
How Supplied
HOW SUPPLIED: 0.45% Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers as follows: Product Code Unit of Sale Strength Each 626050 63323-626-50 Package of 60 0.225 grams per 50 mL (4.5 mg per mL) 63323-626-01 50 mL in a 100 mL free flex ® bag 626100 63323-626-00 Package of 50 0.45 grams per 100 mL (4.5 mg per mL) 63323-626-02 100 mL in a 100 mL free flex ® bag ...
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